Unishield Extra Strength Non-Aspirin

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 500 mg.

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop using and ask a doctor if

■ pain gets worse or lasts more than for more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use more than directed (see overdose warning)

Adults and children 12 years and over

■ take 2 tablets every 6 hours while symptoms last. ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

Children under 12 years Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid, titanium dioxide*.

* may contain

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5855

Unishield Extra Strength Non-Aspirin

Unishield

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

100 Tablets/2Tablets Per Packet

Acetaminophen 500 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves headaches, backaches, muscular aches and more

• Temporarily relieves fever

Compare active ingredients to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

Unishield Extra Strength Non-Aspirin Label